1. Field of Invention
This invention relates to erection aids, specifically to vacuum-constriction erection aid devices used to induce and maintain erections in impotent males.
2. Description of Prior Art
Impotence is a common medical problem affecting over 10,000,000 American males. In the past, psychological impotence was treated primarily by sex therapy while organic (physical) impotence usually was treated by injection therapy or implantation of a penile prosthesis. All of these treatment modalities have major disadvantages. Sex therapy is costly, time consuming, and often ineffective; injection therapy is painful and may induce scarring of the erectile bodies; and penile implants require costly surgical procedures which may result in serious complications. Vacuum-constriction therapy provides an attractive alternative to these standard treatment options because it is a noninvasive, painless, and relatively inexpensive procedure which produces immediate results and can be used in all types of impotence.
Vacuum-constriction therapy employs erection aid devices which produce a partial vacuum around the penis. This vacuum expands the blood vessels in the penis which in turn increases blood flow to the organ and causes it to become erect. After an erection has been achieved, an elastic constriction band is placed around the base of the penis to impede blood flow from the organ and maintain the erection. Prior developments in this field will be generally illustrated by reference to the following patents, publications, and commercial products:
______________________________________ Patent No. Patentee Issue Date ______________________________________ 347,300 Giuseppe Meldi (Italy) 02/22/57 2,874,698 F. W. Sell 03/24/59 4,378,008 Gedding D. Osbon, Sr. 03/29/83 4,741,329 Benjamin F. Marcune 05/03/88 4,753,227 Rudolph R. Yanuck, Jr. 06/28/88 ______________________________________
Witherington R. Suction Device--Therapy in the Management of Erectile Impotence Urol. Clinics North Am. 15:123(1988). PA1 VED.TM. Vacuum Constriction Device--Mission Pharmacal Co., P.O. Box 1676, San Antonio, Tex. PA1 Osbon ERECAID SYSTEM.TM. Erection Inducer--Osbon Medical Systems Ltd., 1253 Broad Street, P.O. Box 1478, Augusta, Ga. PA1 E.I.D..TM. Erection Inducer Device--Performance Medical, Berlin, N.J. PA1 a) forms an airtight seal between modern smooth-walled penile vacuum chambers and the penis; PA1 b) provides a simple method for dislodging a constriction band from a penile vacuum chamber onto the penis; PA1 c) provides a simple, inexpensive means to simultaneously dislodge a constriction band from a penile vacuum chamber and relieve the vacuum in the chamber; and PA1 d) provides a unique constriction band which can be manufactured from simple, inexpensive components.
All of these vacuum-constriction devices, except meldi's, have four essential components--a cylindrical penile vacuum chamber, a vacuum pump, a vacuum release valve, and a constricting elastic band (Osbon patent, supra). There have been numerous modifications of these devices since Dr. Otto Lederer described the first erection aid device in 1917 (Witherington R., supra). A comprehensive review of these is beyond the scope of this discussion, so only those listed above, which relate to our invention, will be reviewed herein.
To achieve a partial vacuum around the penis, the open end of a penile vacuum chamber must make an airtight seal with the penis or the abdominal wall around the penis. Devices which form a junction with the abdominal wall surrounding the penis (Marcune patent, supra) may suck the skin and testicles into the vacuum chamber, causing inconvenience, pain, and injury. Devices which form a seal with the penis require adapter inserts (Osbon ERECAID.TM., supra) to decrease the diameter of the chamber's opening. The adapter inserts are inconvenient to use and may make it difficult to remove the device from the erect penis.
Meldi shows an erection aid device with a penile sealing diaphragm. Meldi's device increases the effectiveness of erection aids designed solely to induce an erection because it makes a tight seal with the penis rather than the abdominal wall. Meldi's erection aid, however, is not a true vacuum-constriction device because it does not have the elastic constriction band which most impotent men require to maintain the erection generated within a vacuum chamber. There are two other significant disadvantages to Meldi's device. First, Meldi's penile sealing diaphragm is designed for use with a vacuum chamber which has a lip of rim to fix the diaphragm to the vacuum chamber. The diaphragm would easily slip off of a chamber which did not have a flanged end. The need for such an attaching means greatly decreases the versatility and applicability of Meldi's device since modern vacuum chambers do not have protruding lips of rims to which the diaphragm could be attached. Present-day vacuum chambers have smooth walls because any protrusion on their distal wall would interfere with band transfer from the chamber to the penis. Second, Meldi's diaphragm is a complex device having a very irregular shape. Because of its complexity, Meldi's diaphragm can not be made from a simple segment of rubber tubing, rather it must be formed by a molding process, a manufacturing technique which greatly increases the cost of producing the device.
Prior-art vacuum-constriction devices also are difficult to operate because the operator must use his fingers to push the constriction band off of the penile vacuum cylinder onto the penis. Recognition of this problem resulted in the development of erection aid devices with an outer sleeve which can be pushed or pulled toward the abdomen to dislodge the constriction band from the penile vacuum chamber to the penis (Sell patent, supra; Yanuck patent, supra). While these devices may facilitate transfer of the constriction band to the penis, their construction entails complicated mechanical alterations of the penile vacuum chamber which are costly to manufacture.
Another disadvantage of prior-art vacuum erectors is the need to perform two separate and distinct functions, to transfer the constriction band from the vacuum chamber to the penis and to relieve the vacuum within the chamber. The sequence of these functions, which may be confusing to elderly males most in need of the device, is important because the erection may be lost if the vacuum is released before the constriction band has been transferred. To obviate these disadvantages Yanuck also shows a vacuum release valve which opens automatically when a sleeve is activated to transfer the constriction band to the penis. This mechanism facilitates the use of erection aid devices, but is complicated and costly to manufacture.
Finally, the constriction bands used to maintain the erection induced in a penile vacuum chamber are expensive to manufacture, difficult to dislodge from the penile vacuum chamber, and difficult to remove from the penis. Strings have been looped around the constriction bands to facilitate their removal from the penis (rubber bands with safety loops, VED.TM. Vacuum Constriction device, supra). Constriction bands also have been made with side loops (Osbon ERECAID.TM., supra) or tabs (E.I.D..TM. Erection Inducer Device, supra) which may be used to pull the bands from the penis. However, such strings easily become tangled in the pubic hair and the loops and tabs are difficult to use because they stretch and become more difficult to grasp when they encircle the erect penis.
The constriction bands also must apply differing degrees of tension to the penis to accommodate variations in penile anatomy. The tension applied by the bands has been increased by doubling the bands (Osbon ERECAID.TM. supra), but this makes them extremely difficult to apply to the vacuum chambers and equally difficult to remove from the penis. Variations in band tension also have been achieved by varying the elasticity of the rubber used to manufacture the bands (E.I.D..TM. Erection Inducer Device, supra), a method which increases the complexity and expense of manufacturing the bands. Also, doubling the bands may create excessive constrictive forces, which may cause gangrene.